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Elevar Therapeutics Names Dong-Gun Kim CEO as It Focuses on Post-NDA Commercialization Strategy

On January 29, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Group and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that Dong-Gun (DG) Kim has been appointed its Chief Executive Officer. He will concurrently retain his roles as CEO of HLB US and CEO of Immunomic Therapeutics, Inc., both affiliated companies within HLB Group.

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At Elevar, DG Kim replaces Dr. Bryan Kim, who will remain CEO of HLB Group’s Verismo Therapeutics, Inc. With Elevar having this week submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration for its top two developmental drugs, the transition allows Bryan Kim to now solely focus on his role with Verismo, which expects to reach several important milestones in the coming year.

On January 23, 2026, Elevar submitted an NDA for the combination of its drug candidate rivoceranib, a VEGFR-TKI, and Hengrui Pharma’s camrelizumab, an anti-PD-1 antibody, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC). HCC is the most common type of liver cancer. Elevar also submitted an NDA on January 27, 2026, for its investigational drug lirafugratinib as a second-line treatment option for cholangiocarcinoma (CCA) with fibroblast growth factor receptor (FGFR2) fusions or rearrangements. CCA is also known as bile duct cancer.

"Bryan Kim has done an exemplary job steering Elevar through the regulatory and developmental steps leading to NDAs for both the rivoceranib-camrelizumab combination in the liver cancer arena and lirafugratinib as a bile duct cancer therapy," said DG Kim, an Elevar board member since 2020. "With this critical phase completed, I look forward to executing on our commercialization strategy while simultaneously working to meet any requests from the FDA during its review of these important applications."

DG Kim previously served as CEO of HLB Co. Ltd. Prior to that, he spent more than 30 years as a specialist in mergers & acquisitions, corporate finance and investment management at leading corporations and professional firms (law, investment banking and private equity) both in the U.S. and Korea. He holds an A.B. in Physics from Harvard College and a J.D. from Harvard Law School.

(Press release, Elevar Therapeutics, JAN 29, 2026, View Source [SID1234662352])

Chugai Announces 2025 Full Year Results and Forecasts for 2026

On January 29, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its consolidated financial results for the fiscal year ended December 31, 2025, and forecasts for the fiscal year ending December 31, 2026.

Chugai reported that revenue for the fiscal year ended December 31, 2025 totaled ¥1,257.9 billion (+ ¥87.3 billion, +7.5%, YoY).

Regarding revenue, domestic sales were ¥472.4 billion (+ ¥11.3 billion, +2.5%, YoY). In the oncology field, sales decreased by 0.5% YoY due to the decrease in Perjeta, which has the same active ingredient as Phesgo, due to Phesgo’s market penetration, and the impact of NHI drug price revisions and penetration of biosimilars on our mainstay product Avastin, despite steady growth of new products Phesgo and Lunsumio, and our mainstay product Polivy. In the specialty field, sales increased by 5.8% YoY, driven by steady performance of mainstay products Vabysmo, Enspryng, and Hemlibra, along with successful market penetration of the new product PiaSky. Overseas sales increased by 12.8%, driven by increases in Hemlibra and Actemra to Roche. Other revenue increased by 4.3%, despite the decrease in one-time income, mainly due to an increase in income related to Hemlibra.

Cost to sales ratio improved by 1.3 percentage points YoY to 32.6%, mainly due to foreign exchange effects and changes in the product mix. Research and development expenses increased to ¥180.1 billion (+1.8%, YoY) due to investments into drug discovery and early development, and increases associated with the progress of development projects, while selling, general and administrative expenses were ¥103.2 billion (+1.0%, YoY) mainly driven by miscellaneous expenses. Other operating income (expense) was ¥0.0 billion. As a result, core operating profit was ¥623.2 billion (+12.1%, YoY) with a core operating profit margin (to revenue) of 49.5%, and core net income increased for the nine consecutive years to ¥451.0 billion (+13.6%, YoY).

Chugai made steady progress in R&D activities for both in-house products and products in-licensed from Roche.

For in-house projects, NXT007, under development for hemophilia A, achieved Proof of Concept (PoC), an important milestone, with data from the high-dose cohort of the Phase I/II trial suggesting the potential to provide blood coagulation capacity equivalent to normal levels. For a Chugai-originated development, orforglipron, an oral GLP-1 receptor agonist out-licensed to Eli Lilly and Company, met the primary endpoints across all multiple Phase III clinical trials for obesity and type 2 diabetes. Based on favorable Phase III clinical trial results, Eli Lilly and Company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for the treatment of obesity. NEMLUVIO, being developed overseas by Galderma, received approval in Europe for moderate to severe atopic dermatitis and prurigo nodularis. AVMAPKI, out-licensed to Verastem Oncology, was approved by the FDA under the accelerated approval pathway based on response rate and duration of response for combination therapy with FAKZYNJA for KRAS-mutant recurrent low-grade serous ovarian cancer.*

*Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

For products in-licensed from Roche, the intravenous formulation of Lunsumio was launched in Japan as a treatment for relapsed or refractory follicular lymphoma, and additional approval was obtained for the subcutaneous formulation. In addition, Elevidys obtained regulatory approval in Japan as a regenerative medicine product for the treatment of duchenne muscular dystrophy under the conditional and time-limited approval pathway. Furthermore, Tecentriq and Vabysmo obtained approvals for expanded indications, and Lunsumio and Avastin have been filed for expanded indications.

For products in-licensed from third parties other than Roche, sparsentan, acquired through the wholly owned subsidiary of Renalys Pharma, Inc., showed positive topline results in a domestic Phase III trial for IgA nephropathy. Sparsentan is scheduled to be filed for regulatory approval in Japan in 2026.

In 2025, Chugai entered into a joint research and license agreement with Gero, which has target discovery technology for age-related diseases, and a license agreement with Rani Therapeutics, whose technology enables oral delivery of biologics and drugs. Chugai will continue to pursue the expansion of its drug discovery engine through open innovation.

In 2026, core revenue, core operating profit, and core net income are expected to be ¥1,345.0 billion (+ ¥87.1 billion, +6.9%, YoY), ¥670.0 billion (+ ¥46.8 billion, +7.5%, YoY), and ¥485.0 billion (+ ¥34.0 billion, +7.5%, YoY), resulting in an increase in both revenue and profit. Product sales are expected to increase in Japan and remain at similar levels to the previous year overseas, totaling ¥1,100.0 billion (+ ¥22.2 billion, +2.1%, YoY). Domestic sales are expected to be ¥498.0 billion (+ ¥25.6 billion, +5.4%, YoY) due to volume growth of new product Lunsumio and our mainstay products, despite a decrease in sales due to NHI drug price revisions and penetration of generics. Overseas sales are expected to be ¥602.0 billion (- ¥3.4 billion, -0.6%, YoY) due to growth in NEMLUVIO and Hemlibra, while a decrease in Actemra and others is expected. Other revenue is expected to be ¥245.0 billion (+ ¥64.9 billion, +36.0%, YoY). Royalty and profit-sharing income are forecasted to be ¥217.2 billion (+ ¥44.5 billion, +25.8%, YoY), due to an increase in income related to products out-licensed to third parties and Hemlibra. Other operating income is expected to be ¥27.8 billion (+ ¥20.3 billion, +270.7%, YoY), due to an increase in one-time income.

[2025 full year results]

Billion JPY 2025 2024 % change
Core results
　Revenue 1,257.9 1,170.6 +7.5%
　　Sales 1,077.8 997.9 +8.0%
　　Other revenue 180.1 172.7 +4.3%
　Operating profit 623.2 556.1 +12.1%
　Net income 451.0 397.1 +13.6%
IFRS results
　Revenue 1,257.9 1,170.6 +7.5%
　Operating profit 598.8 542.0 +10.5%
　Net income 434.0 387.3 +12.1%
[Sales breakdown]

Billion JPY 2025 2024 % change
Sales 1,077.8 997.9 +8.0%
　Domestic sales 472.4 461.1 -0.5%
　　Oncology 246.5 247.7 -0.5%
　　Specialty 225.8 213.4 +5.8%
　Overseas sales 605.4 536.8 +12.8%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025 2024 % change
　Tecentriq 62.8 65.4 -4.0%
　Polivy 37.2 34.1 +9.1%
　Phesgo 33.9 23.5 +44.3%
　Alecensa 33.5 31.0
+8.1%

　Avastin 26.1 33.8 -22.8%
[Specialty field (Domestic) Top5-selling medicines]

Billion JPY 2025 2024 % change
　Hemlibra 62.7 59.0 +6.3%
　Actemra 50.5 48.0 +5.2%
　Enspryng 29.2 24.7 +18.2%
　Vabysmo 26.2 21.5 +21.9%
　Evrysdi 16.2 15.9 +1.9%
[2026 full year forecast](Core-basis)

Billion JPY 2026 Forecast 2025 Actual % change
　Revenue 1,345.0 1,257.9 +6.9%
　Operating profit 670.0 623.2 +7.5%
　Net income 485.0 451.0 +7.5%
[Progress in R&D activities from Oct 25th, 2025 to Jan 29th, 2026]

2025 FY R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

(Press release, Chugai, JAN 29, 2026, View Source [SID1234662351])

BioMarin Announces Pricing of Private Offering of Senior Notes and Completion of
Syndication of New Senior Secured Term Loan Facility

On January 29, 2026 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) ("BioMarin") reported that it priced its previously announced offering of $850 million of 5.500% senior unsecured notes due 2034 (the "Notes"). The issue price of the Notes is 100.000%. The offering is expected to close on February 12, 2026, subject to the satisfaction of customary closing conditions.

BioMarin also announced that, in connection with the pending acquisition (the "Acquisition") of Amicus Therapeutics, Inc. ("Amicus"), it completed the syndication of a new $2 billion senior secured term loan "B" facility (the "Term Loan B Facility"), which Term Loan B Facility is in addition to a $800 million senior secured term loan "A" facility (the "Term Loan A Facility" and, together with the Term Loan B Facility, the "Term Facilities"), and a $600 million senior secured revolving credit facility into which BioMarin expects to enter in connection with the Acquisition (the "New Revolving Facility" and, together with the Term Facilities, the "New Senior Secured Credit Facilities").

BioMarin intends to use the net proceeds from the offering of the Notes, together with borrowings under the Term Facilities and cash on hand, to fund the consideration payable in connection with the Acquisition and related fees and expenses in connection with the Acquisition, the borrowings under the New Senior Secured Credit Facilities, and the issuance of the Notes. The company may also borrow up to $150 million under the New Revolving Facility to pay such fees and expenses.

Gross proceeds from the issuance of the Notes will be deposited into an escrow account at the closing of the Offering, pending consummation of the Acquisition. In the event that the Acquisition is not completed on or prior to December 19, 2026, or upon the occurrence of certain other events, BioMarin will be required to redeem all of the Notes at a redemption price equal to 100% of the initial issue price of the Notes plus accrued and unpaid interest from the date of issuance, or the most recent date to which interest has been paid or provided for, to but excluding the special mandatory redemption date.

The Notes will be jointly and severally guaranteed by certain of BioMarin’s subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities, including, after the closing of the Acquisition, Amicus and certain of its subsidiaries that will guarantee the obligations under the New Senior Secured Credit Facilities.

The indenture governing the Notes is expected to contain customary covenants that, among other things, restrict, with certain exceptions, the ability of each of BioMarin and its subsidiaries to incur additional debt, pay dividends, make certain other restricted payments, incur debt secured by liens, dispose of assets, engage in consolidations and mergers or sell or transfer all or substantially all of its assets.

The Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other securities laws and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from the registration requirements of or in a transaction not subject to the Securities Act and any state or other applicable securities laws. Accordingly, the offering of the Notes is available only to a limited number of persons who are either (1) reasonably believed to be "qualified institutional buyers" as defined in Rule 144A under the Securities Act or (2) non-U.S. persons outside the United States pursuant to Regulation S under the Securities Act. The Notes will be subject to restrictions on transferability and resale and may not be transferred or resold except in compliance with the registration requirements of the Securities Act or pursuant to an exemption therefrom and in compliance with any state or other applicable securities laws.

This press release is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. This press release contains information about the pending offering of the Notes, and there can be no assurance that the offering will be completed. The offering of the Notes may be made only by means of an offering memorandum.

(Press release, BioMarin, JAN 29, 2026, View Source [SID1234662350])

Aprea Therapeutics Announces Early Clinical Proof-Of-Concept in the Ongoing ACESOT-1051 Dose-Escalation Trial Evaluating WEE1 Inhibitor APR-1051, Including Partial Response Observed on First Scan

On January 29, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported the first unconfirmed partial response (uPR) observed in a patient enrolled in its ongoing Phase 1 ACESOT-1051 dose-escalation study (A Multi-Center Evaluation of WEE1 Inhibitor APR-1051 in Patients with Advanced Solid Tumors).

This early clinical activity was observed in a patient with PPP2R1A-mutated uterine serous carcinoma, a form of endometrial cancer, treated at the 150 mg dose level of APR-1051, with dose escalation continuing into higher dose cohorts to establish the recommended Phase 2 dose (RP2D). At the protocol-defined 8-week imaging assessment, the patient achieved a 50% reduction in target lesion size per RECIST v1.1 criteria, along with a marked reduction in cancer antigen 125 (CA-125) levels, from 732 to 70 U/mL, a well-recognized tumor marker in endometrial cancer.

In earlier cohorts of ACESOT-1051 study, multiple patients achieved stable disease with reductions in tumor burden, including a 5% reduction at the 70 mg dose in a patient with HPV-positive head and neck squamous cell carcinoma (HNSCC) and a 15% reduction in a patient with FBXW7-mutated colon cancer treated at the 100 mg dose. This patient has remained on therapy for over 210 days and is approaching their eighth treatment cycle. In addition, a second patient treated at the 150 mg dose level achieved stable disease at the first follow-up imaging assessment.

Collectively, these findings suggest that APR-1051 may have therapeutic potential across a range of solid tumors. Enrollment in the 220 mg dose level cohort of the study is currently underway, and the company intends to increase enrollment of HPV-positive patients in the ongoing trial.

"These early single-agent data demonstrate that APR-1051 has clinical activity as a single agent," said Anthony Tolcher, MD, FRCPC, Principal Investigator at Next Oncology. "The observation of a partial response on the first scan, together with a decrease in tumor marker at this dose level, supports continued clinical evaluation of APR-1051."

Oren Gilad, PhD, Chief Executive Officer of Aprea Therapeutics, added, "These preliminary results provide early proof-of-concept for single-agent activity of APR-1051 and support our strategy of targeting cancers with specific genomic alterations, including HPV-positive disease and PPP2R1A, FBXW7, CCNE1, TP53 and KRAS mutations. The potential dose-response trend and favorable safety profile observed in the ongoing dose-escalation study reinforce our confidence in the potential of APR-1051 as a differentiated WEE1 inhibitor for patients with advanced solid tumors. We look forward to providing additional updates in the first half of 2026 and completing dose escalation later in the year."

About the ACESOT-1051 Trial

ACESOT-1051 is a first-in-human, open-label Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. The dose-escalation portion of the study is expected to enroll up to 50 patients across nine planned dose cohorts, ranging from10 mg to 300 mg administered once daily. APR-1051 is administered orally once daily in continuous 28-day cycles. To date, enrollment has evaluated doses up to 150 mg, with the 220 mg cohort currently enrolling. For more information, refer to ClinicalTrials.gov ID NCT06260514.

(Press release, Aprea, JAN 29, 2026, View Source [SID1234662349])

Aprea Therapeutics Announces $5.6 Million Private Placement Priced At-The-Market Under Nasdaq Rules

On January 29, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported that it has entered into a securities purchase agreement with new and existing healthcare focused institutional investors and certain insiders of the Company to sell an aggregate of 6,288,857 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 6,288,857 shares of common stock, in a private placement priced at-the-market under Nasdaq rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant to be issued is $0.89. The warrants to be issued will have an exercise price of $0.765 per share, will be exercisable immediately upon issuance, and will expire on the two-year anniversary from the effectiveness date of the registration statement covering the resale of the securities purchased in the Offering.

The gross proceeds to the Company from the Offering are estimated to be approximately $5.6 million before deducting the placement agent’s fees and other estimated Offering expenses. The Company intends to use the upfront net proceeds from the private placement for general corporate purposes and for research and development expenses. The Offering is expected to close on or about January 30, 2026, subject to the satisfaction of customary closing conditions.

"We believe this financing will enable us to proactively backfill patients at key dose levels in our ongoing ACESOT-1 dose-escalation study evaluating APR-1051, our WEE1 kinase inhibitor, and this may increase the likelihood of successful dose optimization," said Oren Gilad, CEO of Aprea Therapeutics. "By adding more patients to our safety and early efficacy dataset, we expect to accelerate our ability to define the optimal dose and patient population, which we believe will drive the program toward clinical and value-creating inflection points."

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

(Press release, Aprea, JAN 29, 2026, View Source [SID1234662348])